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Laryngeal Injectables: A Review of Vocal Fold Augmentation Materials Available substances 1960-19781978 1 1978-19861986 2 1986-19961996

Understanding Glottal Insufficiency Failure of the vocal folds to close adequately during vibration Etiology 1.

1 Laryngeal Injectables: A Review of Vocal Fold Augmentation Materials Available substances Sea Change WHICH Laryngeal Injectables should I use and WHEN? Understanding Glottal Insufficiency Failure of the vocal folds to close adequately during vibration Etiology 1. Inability of to place vocal folds into the required prephonatory position Loss of neurologic activity Paralysis/Paresis Scaring of joint 2. Loss of mucosal surface does not allow Bernoulli effect to create closure 1

Physiology of Glottic Closure Physiology of Glottic

Intrinsic laryngeal musculature brings the vibratory

vibratory cycle begins with the vocal folds slightly apart

Mucosal membrane pliability Air movement through the

mucosa together Glottal Insufficiency - Etiology 1.

the phonatory position and the respiratory position

longer pliable and cannot be drawn together by Bernoulli

2 Physiology of Glottic Closure Physiology of Glottic Closure 1. Intrinsic laryngeal musculature brings the vibratory membranes into a nearly closed configuration Vocal fold vibratory cycle begins with the vocal folds slightly apart Titze & Verdolini 1. Intrinsic laryngeal musculature brings the vibratory membranes into a nearly closed configuration Vocal fold vibratory cycle begins with the vocal folds slightly apart Titze & Verdolini 2. Mucosal membrane pliability Air movement through the glottis creates a vacuum and sucks supple vocal fold mucosa together Glottal Insufficiency - Etiology 1. Motion impairment The paralyzed vocal fold rests between the phonatory position and the respiratory position Horizontal Vertical Glottal Insufficiency -Etiology 1. Motion impairment 2. Disorders of vocal fold mucosa Vibratory Membranes are no longer pliable and cannot be drawn together by Bernoulli forces 1. Scaring 2. Sulcus Vocalis 2

3 Injection Laryngoplasty for Unilateral Vocal Fold Paralysis Historically - Injection into paraglottic space for the management of unilateral paralysis to restore the ability to laugh.. Injection Laryngoplasty for Unilateral Vocal Fold Paralysis Historically - Injection into paraglottic space for the management of unilateral paralysis Material placed laterally in the vocal fold because it was recognized that a foreign body reaction occurred to the substance Paraffin Placed laterally Abandoned due to inflammatory response and parffinoma Injection Laryngoplasty for Unilateral Vocal Fold Paralysis Unilateral VF paralysis Historically - Injection into paraglottic space for the management of unilateral paralysis Material placed laterally in the vocal fold because it was recognized that a foreign body reaction occurred against the substance Procedure was resurrected in the 1960 s with Teflon Paste, but considered difficult by Arnold, Montgomery and Dedo Limited number of centers Problem: Immobile VF with normal vibratory surface Solution: Medialize the normal vibratory membrane Lateral Injection 3

Injection Laryngoplasty for Paresis and Mucosal Surface Loss Sea Change X 2 Teflon vocal fold augmentation: failures and management in 28 cases.

Problems Injected material creates inflammation Injected material too stiff to vibrate 1.

Injection indications Transformation from treating paralysis with injection to treating all forms of GI with injection Injection Laryngoplasty How Deep to Place

4 Injection Laryngoplasty for Paresis and Mucosal Surface Loss Sea Change X 2 Teflon vocal fold augmentation: failures and management in 28 cases. Nakayama M, Ford CN, Bless DM.. Otolaryngol Head Neck Surg Sep;109(3 Pt 1): Problems Injected material creates inflammation Injected material too stiff to vibrate 1. Available substances Injection indications Transformation from treating paralysis with injection to treating all forms of GI with injection Injection Laryngoplasty How Deep to Place the Needle Placement of Substance Problems Technical Difficulties Difficult surgical technique 1. Position -How deep to place the needle 2. Once substance leaves needle it will flow through the path of least resistance into a resting position 3. How much substance to add Traditional placement Cartilage Perichondrium Early proposed placement for collagen substance TA Muscle TA Muscle Fascia Paraglottic Space 4

Position of Needle and Placement of Substance Influenced by size of needle used to inject Size of needle is determined by choice of substance Fat 18 or 19 g needle required for viability of cells

5 Position of Needle and Placement of Substance Influenced by size of needle used to inject Size of needle is determined by choice of substance Fat 18 or 19 g needle required for viability of cells Teflon 19 g needle Collagen compounds 23 to 27 g needle Calcium Hydroxylapatite 25 to 27 g needle Position of Needle and Placement of Substance Influenced by choice of substance Collagen suggested to have a greater half life and graft stability if injected superficially Ford Remacle Teflon and Calcium Hydroxylapatite produce inflammation Inject laterally Potential Resting Positions for Injected Substances Within TA Muscle Potential Resting Positions for Injected Substances Within Vocal Ligament Lateral Intermediate Medial Just Deep to the Ligament Reinke s Space 5

6 Potential Resting Positions for Injected Substances Outside of Larynx FEMALE Vocal Fold Height MALE n Mean (mm) SD p = Extrusion in Female Larynx Lateral injection of greater than 0.4 ml of substance Extruded Approaching Non-Extruded Favorable Resting Positions for Injected Substances Substance Follows Path of Least Resistance after Injection Pattern of Deposit Lateral Intermediate Medial Multilobular distribution 6

7 Female Volume Required (ml) Cadaver Experiments Medial TA Injection / Lateral TA Injection / p < Problems Related to Choice of Substance More Severe with Medial Injection 1. Viscosity mismatch between the injected substance and the normal lamina propria Chan and Titze Male / p = / p = 0.03 p < Host reaction to the substance Inflammation and granuloma formation with potential airway obstruction Stiffening of vibratory cover Teflon Granuloma Preoperative Laundry List of Available Substances Temporary (2-5 mos) Long-term/Permanent Gelfoam Radiesse Voice Gel Novielle Gel Collagen Products Zyplast (bovine) Cosmoplast (human) Cosmoderm (human) Cymetra Hyaluronic Acid Gels Restylane, Perlane Rooster Combs Hyalan, Hyalan Plus Bacterial fermentation Autologous fat/fascia Radiesse (CaHA)? Novielle Gel Plus? Teflon Limited role 7

8 Gelatin Bovine gelatin Sterile powder (1 gm) Gelfoam Longest track-record record of laryngeal injectables 30+ years #1 injectable substance ABEA survey, 2004 (Merati) Results Short acting (6 weeks) Must use 18g needle for injection Limited use in modern day practice Collagen-Based Injectables Zyplast Longest track record (20+ yrs) Least expensive Bovine-derived Immunogenicity / Skin testing recommended Cymetra Micronized cadaveric dermis No skin testing Prep. Required Cosmoplast/Cosmoderm Human engineered collagen No skin testing No track record Collagen-Based Injectables Collagen-Based Injectables Most are packaged prepared syringes Cymetra TM Requires reconstitution Clumping within needle All flow better if warmed to body temperature prior to injection Can be injected through 24 to 27 g needles Longevity 2-5 months Product Zyplast Collagen Yrs. Material 20+ Bovine collagen Cymetra 4+ Cadaveric Dermis CosmoplastCos moderm <1 Human- engineered Length of effect Pros 4-6 mos Long track record 2-4 mos No allergy? No allergy Cons g Price Allergy Delay Prep time Unpredict. No track record 27 $165 $ $235 $205 8

9 Hyaluronic Acid Injectable Hyalan Gels Introduced as in injectable in Europe 1996 Product Source Rheologic Properties Particle size Used in Facial Plastics to fill wrinkles (FDA clearance 2004) Hylaform Rooster combs Elastic µ Naturally occurring Glycosaminoglycan (polysaccharide) within the dermis or LAMINA PROPRIA Functions to control tissue viscosity by binding water Produced in response to injury *Perlane Bacterial fermentation Viscous 100 µ Restylane µ Produced from 2 sources Avian protein Recombinant forms Restylane Fine Lines µ * = not available in USA Hyalan Gels Radiesse Voice Gel Longevity Reported as 4 to 6 months Personal experience is 2 to 4 weeks Low tissue reactivity Sugar No antigenic qualities Low level of protein impurities Hypersensitivity 0.6% Carbomethylcellulose Wood-based No allergy Gel carrier substance in Radiesse Shorter duration (2-3 months) FDA-approved for use in larynx 9

Radiesse Voice Gel TM Radiesse Voice Gel: Clinical Findings Packaged with needles for injection No

mixing, warming, loading Off the shelf use Results Easy to inject Well tolerated Minimal inflammatory reaction

temporary and manufacturer is working to produce substance with known resorption rate Minimal experience (n =

10 Radiesse Voice Gel TM Radiesse Voice Gel: Clinical Findings Packaged with needles for injection No pre-treatment e.g. mixing, warming, loading Off the shelf use Results Easy to inject Well tolerated Minimal inflammatory reaction Longevity 2 to 6 months Patent protected material Uncertain of contents Novielle Gel TM Intended to be temporary and manufacturer is working to produce substance with known resorption rate Minimal experience (n = 2) 1 early resorption 1 misplaced into LP and needed surgical removal due to lack of resorption at 3 months Glottic Injectables: Long-lasting substances Teflon Autologous fat and fascia Radiesse TM Novielle Gel Plus TM 10

Teflon Lipoinjection Designed for the management of unilateral paralysis

for poor outcomes Viscosity mismatch Poor placement Migration Giant cell

Preparation can be troublesome 2. Length of response is unpredictable 3.

Bone and Teeth Mineral Component Used as solid implant for 20 years

11 Teflon Lipoinjection Designed for the management of unilateral paralysis Ford reported poor outcomes when injected into mobile vocal folds Reasons for poor outcomes Viscosity mismatch Poor placement Migration Giant cell foreign body reaction Teflon Granuloma 1. Preparation can be troublesome 2. Length of response is unpredictable 3. Need for over injection Calcium Hydroxylapatite (CaHA) Found naturally in Bone and Teeth Mineral Component Used as solid implant for 20 years Dentistry Orthopedics Maxillofacial Reconstruction Well tolerated as biologic implant OVER INJECTION REQUIRED 11

Radiesse TM Spherules of Calcium Hydroxylapatite CaHydroxylapatite - histology Suspended in aqueous gel Water, glycerin, carbomethylcellulose (CMC) 25-45 microns in diameter Can pass through 27 gauge

12 Radiesse TM Spherules of Calcium Hydroxylapatite CaHydroxylapatite - histology Suspended in aqueous gel Water, glycerin, carbomethylcellulose (CMC) microns in diameter Can pass through 27 gauge needle or larger 12 months (40x) Forms a scaffolding for tissue in-growth FDA Approved for Vocal Fold Augmentation Radiesse TM Special Considerations Material flows better if slightly warmed Requires moderate hand pressure at start of injection Slight Overinjection (5-10%) is required to adjust for the lost of the carrier material Temporary VF stiffness for 1-2 months following injection, worse if injection is placed superficially Radiesse TM Indications/Duration Permanent augmentation of the vocal fold Paralysis Paresis Atrophy Atrophy NOT SCAR Duration 1 to 2 years clinical experience Bioform reports up to two years, but unknown 12

13 Novielle Gel Plus TM Laundry List of Available Substances Temporary (2-5 mos) Long-term/Permanent Patented carrier substance plus CaHA Newly available Minimal clinical experience Gelfoam Radiesse Voice Gel Novielle Gel Collagen Products Zyplast (bovine) Cosmoplast (human) Cosmoderm (human) Cymetra Hyaluronic Acid Gels Restylane, Perlane Rooster Combs Hyalan, Hyalan Plus Bacterial fermentation Autologous fat/fascia Radiesse (CaHA)? Novielle Gel Plus? Teflon Limited role Conclusions Understand physiology of glottic closure Vocal folds need to be placed in a nearly closed prephonatory position Mucosal surface must be supple Determine why you are injecting Motion impairment Loss of vibratory cover Conclusions Know the characteristic of substance you are injecting Host reaction Longevity may be affected by position Needle size required for injection Understand your ability to vary the placement of the substance in the vocal fold 13

Adipose rabbit mesenchymal stem cells for the treatment of the chronic scar tissue of the vocal cords

Adipose rabbit mesenchymal stem cells for the treatment of the chronic scar tissue of the vocal cords Dr. Vasiliki E Kalodimou, Head of Flow Cytometry-Research and Regenerative Medicine Department, IASO-Maternity